NCT02855489

Brief Summary

This study has three primary goals. First, to design distinct interventions that target the three core constructs of the Theory of Planned Behavior (i.e, attitudes, norms, and perceived behavioral control (PBC)). The second goal is to determine which combination of the Theory of Planned Behavior constructs is more successful at changing condom use behavior among college students. Finally, the investigators will examine the impact change in targeted constructs has on those not targeted by an intervention. The current study intends to empirically test how the constructs (i.e., attitudes, norms, PBC) in the Theory of Planned Behavior influence each other to increase condom use with college students.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 26, 2016

Last Update Submit

July 27, 2023

Conditions

Keywords

Condom UseHIV/STDInterventionTheory of Planned BehaviorDismantling Study Design

Outcome Measures

Primary Outcomes (1)

  • Risky Sexual Behavior

    Risky sexual behavior was a composite variable calculated using "how many times a participant had sex in the past 3 months" X "how many times they used a condom when having sex during those 3 months" (reverse coded). Higher scores indicated riskier sexual behavior.

    Three Months

Secondary Outcomes (1)

  • Condom Use

    Three Months

Study Arms (7)

Attitudes Only

EXPERIMENTAL

The attitudes condition targeted cognitive and affective attitudes by pairing attitudinal messages with pictures, and included an evaluative conditioning task.

Behavioral: Attitudes Only

Norms Only

EXPERIMENTAL

The norms condition utilized a group-affirmation exercise, personalized feedback, and group norms in an attempt to greater condom use norms.

Behavioral: Norms Only

Perceived Behavioral Control Only

EXPERIMENTAL

The PBC condition included a condom application video, lubrication instructions, condom negotiation videos, and a detailed description regarding purchasing condoms.

Behavioral: Perceived Behavioral Control Only

Intentions Only

EXPERIMENTAL

The intentions condition utilized implementation intentions in order to create condom use intentions.

Behavioral: Intentions Only

Three Constructs

EXPERIMENTAL

A three construct condition, which included attitudes, norms, and perceived behavioral control represented the core components of the TPB that are thought to work through intentions to result in behavior change.

Behavioral: Three Constructs

Four Constructs

EXPERIMENTAL

A four construct condition (i.e., attitudes, norms, PBC, and intentions) was designed to represent the "full TPB model" intervention which we expected would be more successful than either the three-construct intervention or any of the single construct interventions.

Behavioral: Four Constructs

No-Treatment, Control

NO INTERVENTION

A no-treatment control condition, which solely consisted of pretest and posttest assessments, was included. This allowed us to obtain important information about how the theoretical constructs in the TPB change over time (or do not) in the absence of an experimental manipulation.

Interventions

Attitudes OnlyBEHAVIORAL
Attitudes Only
Norms OnlyBEHAVIORAL
Norms Only
Perceived Behavioral Control Only
Intentions OnlyBEHAVIORAL
Intentions Only
Three Constructs
Four ConstructsBEHAVIORAL
Four Constructs

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants must be 18 and older and must have had vaginal or anal intercourse at least once.

You may not qualify if:

  • Prior research has indicated that the predictors of condom use are dramatically different in casual versus serious relationships and that condom use is extremely difficult to change among those in established long-term relationships. Thus, we will exclude participants if they indicate that they are in a relationship and they classify that relationship as someone they are "living with" or "married to".

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Reid AE, Aiken LS. Integration of five health behaviour models: common strengths and unique contributions to understanding condom use. Psychol Health. 2011 Nov;26(11):1499-520. doi: 10.1080/08870446.2011.572259. Epub 2011 Jun 28.

    PMID: 21678166BACKGROUND
  • Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health. 2010;31:399-418. doi: 10.1146/annurev.publhealth.012809.103604.

    PMID: 20070207BACKGROUND
  • Glanz K, Maddock J. On judging models and theories: research and practice, psychology and public health. J Health Psychol. 2000 Mar;5(2):151-4. doi: 10.1177/135910530000500203. No abstract available.

    PMID: 22049003BACKGROUND
  • Noar SM. Behavioral interventions to reduce HIV-related sexual risk behavior: review and synthesis of meta-analytic evidence. AIDS Behav. 2008 May;12(3):335-53. doi: 10.1007/s10461-007-9313-9. Epub 2007 Sep 21.

    PMID: 17896176BACKGROUND
  • Godin G, Kok G. The theory of planned behavior: a review of its applications to health-related behaviors. Am J Health Promot. 1996 Nov-Dec;11(2):87-98. doi: 10.4278/0890-1171-11.2.87.

    PMID: 10163601BACKGROUND
  • Webb TL, Sheeran P. Does changing behavioral intentions engender behavior change? A meta-analysis of the experimental evidence. Psychol Bull. 2006 Mar;132(2):249-68. doi: 10.1037/0033-2909.132.2.249.

    PMID: 16536643BACKGROUND
  • Montanaro EA, Kershaw TS, Bryan AD. Dismantling the theory of planned behavior: evaluating the relative effectiveness of attempts to uniquely change attitudes, norms, and perceived behavioral control. J Behav Med. 2018 Dec;41(6):757-770. doi: 10.1007/s10865-018-9923-x. Epub 2018 Apr 18.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 4, 2016

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share